Study on MPDL3280A with Chemotherapy and Radiation for Lung Cancer

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT02525757

Provider View

This clinical trial is exploring the safety of adding a new drug, MPDL3280A, to standard chemotherapy and radiation treatments for patients with non-small cell lung cancer (NSCLC) that cannot be removed by surgery and has not spread.

Patient Parameters

Program Overview

The purpose of this study is to determine if adding MPDL3280A to the usual chemotherapy drugs (carboplatin and paclitaxel) and radiation therapy is safe for patients with non-small cell lung cancer (NSCLC) that cannot be surgically removed. MPDL3280A is an experimental drug not yet approved by the FDA, while the chemotherapy drugs and radiation are already approved for lung cancer treatment. This study will involve up to 40 participants at MD Anderson.

Description

In this study, participants will be divided into two groups. Each cycle of treatment lasts 21 days. Group 1 will receive standard chemotherapy and radiation for 6-7 weeks, followed by a rest period of 3-8 weeks without treatment. Group 2 will receive MPDL3280A along with chemotherapy and radiation for 6-7 weeks, followed by a 3-4 week rest period where they will receive one dose of MPDL3280A but no chemotherapy or radiation. After the rest period, both groups will receive MPDL3280A with chemotherapy for two cycles (consolidation period), and then MPDL3280A alone for up to one year (maintenance period). During the first dose of MPDL3280A, vital signs will be closely monitored to check for any reactions. If chemotherapy is stopped due to side effects, MPDL3280A will also be stopped. Weekly visits during the first 7 weeks will include physical exams and blood tests. After the rest period, during the consolidation period, participants will have exams, blood tests, and scans to check the cancer's status. During the maintenance period, exams and scans will be done every two cycles for up to a year. If the cancer returns, additional tests and scans will be conducted. Participants may receive the study drug for up to a year unless the cancer worsens or side effects become intolerable. Follow-up visits will occur every 2-4 months for up to two years after the last dose, and then every 4-6 months as needed. If unable to visit MD Anderson, participants may receive follow-up calls every 3-6 months for four years.

Eligibility Criteria

Inclusion Criteria

  • Able and willing to provide informed consent and follow study requirements.
  • Age 18 or older.
  • Have a tumor sample available for testing.
  • Diagnosed with non-small cell lung cancer that cannot be removed by surgery and has not spread.
  • Adequate blood and organ function based on specific lab tests.
  • Measurable disease according to standard criteria.
  • Agree to use effective contraception during and after the study.
  • ECOG performance status of 0, 1, or 2, indicating ability to receive chemotherapy and radiation.
  • Stable blood clotting times unless on anticoagulation therapy.

Exclusion Criteria

  • Cancer that has spread to distant organs.
  • Recent cancer treatments within 3 weeks before starting the study.
  • Significant liver disease or certain blood cancers.
  • Pregnant or breastfeeding women.
  • Allergies to certain cell products or antibodies.
  • Unable to comply with study procedures.
  • History of autoimmune diseases or lung conditions.
  • HIV or active hepatitis infections.
  • Recent severe infections or major surgeries.
  • Recent live vaccines or other cancer treatments.
  • Severe allergic reactions to certain antibodies.
  • Previous organ transplants.

Locations

FACILITYZIPCITYSTATE
MD Anderson Cancer Center77030HoustonTexas

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